Bristol-Myers and Seattle Genetics move a promising flagship combo into PhIII

Jonathan Drachman, Seattle Genetics CMO

Late last year investigators for Bristol-Myers Squibb $BMY and Seattle Genetics $SGEN turned up at ASH with some stellar pilot data from a Phase I/II combination study matching Opdivo with Adcetris. In addition to a 90% objective response rate in a small group of patients, the team also tracked a 62% complete response rate among treatment-resistant patients for classical Hodgkin lymphoma.

Now the partners want to see if they can get similar results in a pivotal Phase III matchup.

The two companies headed to ASCO this morning with an announcement that they’ll be pushing into the Phase III soon, which will compare the combo against Adcetris as a monotherapy.

The move into Phase III comes as the first wave of hundreds of Phase I/II exploratory studies have begun to deliver a trove of data about the potential of these new combos. This week EP Vantage highlighted 765 combination studies in the industry pipeline as cancer combos become one of the hottest tickets in drug R&D. And a new slate of Phase III studies — including a recently announced slate of pivotal tie-ups for Incyte — point to the near-term introduction of new, more effective therapies.

The addition of Adcetris and Opdivo helps illustrate the potential. Opdivo, like 4 other approved PD-(L)1s, dismantles a brake cancer cells have been able to put on an attack by immune cells. Adcetris is a targeted attack. And there’s a large second wave of PD-(L)1s coming through the pipeline.

This is just the first of what could potentially prove to be a series of late-stage studies for these two companies, which have also been running through trials on a range of indications focused on relapsed or refractory Hodgkin lymphoma and CD30-expressing relapsed or refractory non-Hodgkin lymphomas. The studies include T-cell lymphomas, diffuse large B-cell lymphoma (DLBCL), and other rare subtypes of B-cell malignancies, including mediastinal B-cell lymphoma and mediastinal gray zone lymphoma.

Seattle Genetics CMO Jonathan Drachman said:

We are evaluating Adcetris in novel combinations in order to identify optimal treatment regimens for patients with CD30-expressing lymphomas. We are pleased to expand this collaboration with Bristol-Myers Squibb to evaluate Adcetris compared to the combination of Adcetris and Opdivo in a pivotal phase 3 study in relapsed Hodgkin lymphoma.

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